Over the past decades, the Life science industry has progressively introduced computer systems to support manufacturing, control and logistics processes. As a consequence, these became critical elements from the point of view of GxP regulations and, therefore, the Health Authorities have significantly increased their pressure on their role and on the data they manage.
As a result of this pressure, in regulatory inspections we can see an increasing number of observations related to computerized systems, with special relevance to those aspects related to Data Integrity. These observations can lead to serious problems with direct consequences on the business and corporate image.
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In this situation, the regulated industry is forced to increase the technical approach in the validation of its computerized systems, as well as its management practices, in order to meet expectations in regulatory inspections.
Rephine is a global consulting company that is recognized as a pioneer and leader in the validation of computerised systems. Rephine always carried out these activities according to high technical and quality standards, aware of the applicable regulations, current practices and the needs of each client. These values have allowed the generation of methodologies, criteria and state-of-the-art documentation over time, which has satisfied the most stringent requirements of the inspectors in multiple audits of health authorities and clients.
We have a team of international consultants with extensive knowledge of the technologies and computer systems used in the pharmaceutical industry. Sensitive to the flexibility required by our clients, we adopt the role that best suits each case: from “turnkey” projects where the client’s effort is minimized, to ad-hoc consulting. Always providing a collaborative environment, in order to generate internal knowledge to guide their current practices and future decisions.
We provide extensive GMP consulting services to help keep our clients ahead of the needs and expectations of regulators.
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